Threatened Preterm LabourNCT06752161
Urinary Infection in Pregnant Women with Urinary Infection
An observational study of Threatened Preterm Labour, run by Assiut University at 1 site in Egypt.
Trial summary
Urine analysis and culture in patients with threatened preterm labour Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Threatened Preterm Labour
- What is being tested?
- Urine analysis
- How many people
- 224 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with threatened preterm labor
Who may be able to join
- pregnant women with preterm labor
Who cannot join
- renal disease Intrauterine fetal death
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Women's Health Hospital
Asyut
Women Hospital, 0882414916, ethics_committee12@yahoo.com
About this study
Official title: Urinary Tract Infections in Patients with Threatened Preterm Labor
Urine analysis and culture in patients with threatened preterm labour
Read the detailed description
UTI is an infection of the kidneys, bladder, or urethra. Infectious cystitis is the most common type of UTI, which is caused by a bacterial infection of the bladder. Lifetime incidence of UTIs is 50% to 60% in adult women.UTIs are among the most common conditions encountered in primary care, hospitals, and extended care facilities . Total direct costs of UTI treatment (without cultures) have been estimated at US $25.5 billion annually.Despite an exceptionally high prevalence of bacteriuria in the population, these infections rarely cause significant renal damage.Sexual intercourse is the strongest risk factor. Any lifetime sexual activity and any sexual activity during the past year are strongly associated with recurrent UTI. Even the relatively small amounts of spermicide coating condoms increases the risk of UTI. Post-menopausal absence of oestrogen is a risk factor for UTIs. Topical oestrogen reduces UTIs in post-menopausal women; Oestrogenisation of the vaginal mucosa promotes lactobacilli colonisation, which reduces the presence of uropathogens and thus the risk of UTIs and is not recommended over the use of topical oestrogen therapy. Urinary incontinence and oestrogen supplementation have also been associated with UTI in older women, although the reasons for this are incompletely understood. positive family history of UTIs is associated with a two- to fourfold increase in risk of recurrent UTI . Bacteriuria occurs in the presence of indwelling or intermittent catheters, and asymptomatic bacteriuria does not require treatment. Gestational and pregestational diabetes are considered a more predominant risk factor in older women.
- Conditions
- Threatened Preterm Labour
- Being tested
- Urine analysis
- Keywords
- UTI, Preterm labour
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine analysisOther
Urine analysis and culture for Screening and diagnostic tools for UTI in pregnant women
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with threatened preterm labour | Patients with UTI and preterm labour Receives: Other: Urine analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
percent of urinary tract infections in threatened preterm labor
Percentage of women with threatened preterm labor diagnosed with urinary tract infection
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Feb 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Threatened Preterm LabourStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Gamal M.fekry, Assiut University
- Investigators
- Mohammed Seif al nasr, MBBCH, Principal investigator, Women's Health Hospital Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752161
- Sponsor's protocol ID
- UTIP
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tract Infections in Patients with Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT06752161
- Acronym / sponsor ID
- UTIP
- Conditions
- Threatened Preterm Labour
- Keywords
- UTI, Preterm labour
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 30 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Urine analysis and culture in patients with threatened preterm labour
Detailed description
UTI is an infection of the kidneys, bladder, or urethra. Infectious cystitis is the most common type of UTI, which is caused by a bacterial infection of the bladder. Lifetime incidence of UTIs is 50% to 60% in adult women.UTIs are among the most common conditions encountered in primary care, hospitals, and extended care facilities . Total direct costs of UTI treatment (without cultures) have been estimated at US $25.5 billion annually.Despite an exceptionally high prevalence of bacteriuria in the population, these infections rarely cause significant renal damage.Sexual intercourse is the strongest risk factor. Any lifetime sexual activity and any sexual activity during the past year are strongly associated with recurrent UTI. Even the relatively small amounts of spermicide coating condoms increases the risk of UTI. Post-menopausal absence of oestrogen is a risk factor for UTIs. Topical oestrogen reduces UTIs in post-menopausal women; Oestrogenisation of the vaginal mucosa promotes lactobacilli colonisation, which reduces the presence of uropathogens and thus the risk of UTIs and is not recommended over the use of topical oestrogen therapy. Urinary incontinence and oestrogen supplementation have also been associated with UTI in older women, although the reasons for this are incompletely understood. positive family history of UTIs is associated with a two- to fourfold increase in risk of recurrent UTI . Bacteriuria occurs in the presence of indwelling or intermittent catheters, and asymptomatic bacteriuria does not require treatment. Gestational and pregestational diabetes are considered a more predominant risk factor in older women.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with threatened preterm labour | – | Other: Urine analysisPatients with UTI and preterm labour |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with threatened preterm labor
Key inclusion criteria (1 listed)
- pregnant women with preterm labor
Key exclusion criteria (1 listed)
- renal disease Intrauterine fetal death
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine analysisUrine analysis and culture for Screening and diagnostic tools for UTI in pregnant women | Other | Pregnant women with threatened preterm labour |
Primary outcome
percent of urinary tract infections in threatened preterm labor
Time frame: 1 month
Percentage of women with threatened preterm labor diagnosed with urinary tract infection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Seif al nasr, MBBCH principal investigator
Women's Health Hospital Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Threatened Preterm Labour, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Fekry, PhD (0882312388, mohamedbeethoven2040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percent of urinary tract infections in threatened preterm labor (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.